De-Intensification of Postoperative Radiotherapy in Patients with Squamous Cell Carcinoma of the Head and Neck
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.
• Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
• Surgery of primary tumor and neck dissection performed according to predefined surgical standard
• Indication for postoperative radio(chemo)therapy
• No lymph node metastases \> 6cm
• Lymph node metastases in not more than 3 lymph node level
• No distant metastases (cM0)
• Age ≥ 18 years, no upper age limit
• Eastern Cooperative Oncology Group (ECOG) ≤ 2
• Patients who understood protocol contents and are able to behave according to protocol
⁃ Signed study-specific consent form prior to therapy
⁃ Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)